Method of preparing endometrial samples

ABSTRACT

There is disclosed herein an aspiration and method of using same for obtaining cell samples from the walls of a body cavity and designed particularly for obtaining samples from the lining of the uterus. The device comprises a tubular member, fenestrated at one end and adapted for connection to a hypodermic syringe at the other end and a tubular sleeve over the surface of the tubular member which is moved from a position near said adapter to a position covering the fenestrae on the end of the tube, whereby fluids pulled into the tubular member through the fenestrae can be ejected from the end of the tube for study.

Muenzer METHOD OF PREPARING ENDOMETRIAL I SAMPLES [75 inventor:

Robert W. Muenzer, Toledo, Ohio Dow Corning Corporation, Midland, Mich.

July 22, 1971 Assignee:

U.S. Cl. 128/2 B, 128/241, 128/278 Int. Cl A61b 10/00 Field of Search128/2 B, 239, 240,

[56] References Cited UNITED STATES PATENTS 11 Oct. 23, 1973 2,826,1973/1958 Leonard 128/245 9/1970 Gravlee .f. 128/213 PrimaryExaminer-William E. Kamm Attorney-Robert F. Fleming, Jr. et al.

57 ABSTRACT There is disclosed herein an aspiration and method of usingsame for obtaining cell samples from the walls of a body cavity anddesigned particularly for obtaining samples from the lining of theuterus. The device comprises a tubular member, fenestrated at one endand adapted for connection to a hypodermic syringe at the other end anda tubular sleeve over the surface of the tubular member which is movedfrom a position near said adapter to a position covering the fenestraeon the end of the tube, whereby fluids pulled into the tubular memberthrough the fenestrae can be ejected from the end of the tube for study.3 1

' 1 Claim, 2 Drawing Figures PATENIEDBIZT 2 7 3. 76 6. 907

F/g. J

INVENTOR ROBERT W. MUENZER Waz 24*...

ATTORNEY BACKGROUND OF THE INVENTION The present invention relates tomethods for obtaining cell samples from within living bodies and isparticularlydesigned to obtaining endometrial samples for Papanicolaouscreening (Pap smears), in detection of cervical and uterine cancer.

Various methods of obtaining such cell samplings have been devised andhave shown encouraging results in the early detection, particularly ofcervical carcinoma. These devices include, for example, endometrialbrushes, endometrial washers, and scrapers and curettes of variousshapes. While it is relatively easy to obtain samplings of the liningmucus of the vagina and mouth of the cervix, it has been at bestdifficult to obtain reliable samples from the uterus.

Endometrial carcinoma is a disease where the average age of the patientis considerably older than in the case of cervical carcinoma, and inmany cases involves the post-menopausal woman. Under such conditions thecervical canal is not as patulous as in the younger menstruating woman.Any of the previous devices for obtaining uterine samples for cytologicstudies have proven to be sufficiently large that painful dilation ofthe cervix isneeded to pass the test instrument through the cervix andinto the uterine cavity. Because of the pain involved in obtaining aspecimen, patients are reluctant to accept routine yearly-typeexamination, which would likely result in earlier detection of thedisease. Routine vaginal and cervical smears are unsatisfactory for usein detecting endometrial carcinoma due to the fact that the endometriumdoes not exfoliate as readily as the cervix or vagina. Accordingly, thenumber of cells reaching the vaginal pool for easy access is relativelysmall and the cells themselves frequently degenerate, whereby the wholesample is heavily diluted by material from the cervix and the vagina.

SUMMARY OF THE INVENTION It is, therefore, an object of the presentinvention to provide a method for collecting cell samples from theendometrium, which avoids the aforementioned problems with the prior artand which is more likely to gain patients acceptance for a routineregular type examination.

In accordance with these and further objects, there is provided by thepresent invention an aspiration device for collecting cell samples fromthe walls of body cavities comprising a first elongated open-endedtubular member adapted for insertion into the body cavity and havingmeans for attachment to a source of vacuum and pressure at one end whilebeing fenestrated at its other end so that samples are collected from arelatively large area as vacuum is applied to aspirate fluids into thedevice. Further, a second tubular sleeve member having an internaldiameter approximating the external diameter of the first tubular memberand a length at least as long as the fenestrated portion of the firstmember is slidably positioned on the first member and movable fromaposition distant from the fenestrated portion to a position covering thefenestrae whereby upon application of pressure to the first member, thefluid samples drawn into the member through the fenestrae can all beejected from the end of the tube, for examination ona microscopeslide,for example.

Additionally, a stylet may be positioned inside the first member forease in insertion of the first member into the desired body cavity. Thestylet is, of course, removed prior to aspiration of fluidsinto thedevice.

The first tubular member may be made of extremely fine tubing so that aminimum of dilation will be required for insertion of the fenestratedend of the tube into the uterus through the cervix. Similarly, the sametype ofdevice can be used to obtainrsamples from other body cavities.

BRIEF DESCRIPTION OF THE DRAWING Other objects and advantages willbecome apparent from the following detailed description when read inconjunction with the accompanying drawing illustratingapreferredembodiment of this invention, in which:

FIG. 1 is a view in perspective of an aspiration device made inaccordance with thepresent invention showing the insertion stylet inplace, and

FIG. 2 is a view in perspective of the aspiration device of FIG. 1showing the stylet removed, a hypodermic syringe in place for providingvacuum and pressure to the device, and the slidable sleeve positionedover the fenestrated end of the device.

DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawingswherein corresponding parts are given like reference numerals throughoutthe figures thereof, there is shown in FIG. 1 afirst elongatedopen-ended tubular member 11 which is desirably made of a siliconerubber, but which may be made of any other suitable material. Attachedto the proximal end of the tubular member 11, is an attachment means 12for attachment of the device to a suitable source of vacuum and pressurefor aspiration of fluids into the tubular member 11 and ejection of thefluids therefrom. Such a suitable device is a hypodermic syringe 13 asmay be seen in FIG. 2. The distal portion 14 of the tubular member 1 lis fenestrated so that upon application of vacuum by withdrawal of theplunger of the syringe l3 fluids enter the bore of the .tube 14 from arelatively wide area of, contact. The fenestrae also provide insurancethat even though some of the fenestrae may be plugged by debris anadequate sampling can still be obtained.

As shown in FIG. 1 there is positioned on the surface of the tubularmember 11 a second tubular sleeve member 16 which has a length at leastthat of the fenestrated portion of the first member 11 and an internaldiameter approximating the external diameter of the first member.Thejsleeve member 16 is selectively positionable from the position shownin FIG. 1 adjacent to the attachment adapter 12 to the position shown inFIG. 2, wherein the fenestrated portion of the first tubular member 11is completely covered by the sleeve 16. In the position where thefenestrated portion of the tube is covered the relatively closeapproximation of diameters form a substantial seal of the fenestrae sothat upon application of pressure by pushing the syringe plunger anyfluids which have been collected are ejected from the distal end of thebore of the tubular member 11. Thus, all fluids can be concentratedeasily in one area on a microscope slide for subsequent examination.

Particularly when the device is to be used for obtaining endometrialsamples it is desirable that a stylet 17 having a handle 18 affixedthereto, is threaded through the tubular member 11 (FIG. 1) to stiffenthe tubular member during insertion. The stylet 17 should have a lengthsuch that it does not protrude beyond the distal end of the tube 11. Onthe other hand, the stylet should come substantially to the very end ofthe tubular member 11, when it is wholly inserted, to prevent any easybending of the distal portion of the tube 11.

In operation the stylet, if one is used, is inserted into the open endof the adapter 12, and the distal end of the tubular member 11 isinserted into the cervix. During insertion the tubular sleeve member 16is kept in a position abutting or adjacent the adapter or attachmentmeans 12. When the fenestrated portion 14 has been positioned in theuterus the stylet 17 is withdrawn from the device simply by pulling onthe handle 18. The hypodermic syringe 13 or other source of vacuum isthen affixed to the adapter 12 and a vacuum is drawn to draw fluids intothe bore of the tube 11 through the fenestrae 14. The device iswithdrawn from the uterus and cervix and the sleeve 16 is thenpositioned over the fenestrated portion 14 before applying pressure tothe fluid by depression of the plunger of the hypodermic syringe toeject the fluid from the device.

In a particular embodiment of the device, the tubular member 11consisted of a 7% inch length of silicone rubber tubing havingfenestrations over the distal 1% inches of the length. The tubingdiameter was 0.085 inch external and 0.04 inch internal diameter.

It is understood that other variations and modifications of theinvention will become apparent to those skilled in the art from areading of the foregoing. It is therefore to be understood that withinthe scope of the appended claims the invention may be practicedotherwise than as specifically described.

That which is claimed is: l. A method of preparing endometrial samplesfor microscopic examination comprising:

inserting through the cervix one end of a first elongated flexibletubular member having an ejector port at said end and having fenestraethrough the tubular wall adjacent said (end) ejector port and having asecond tubular member having an internal diameter approximating theexternal diameter of said first tubular member and being slidablycoaxially mounted on said first member at a position spaced from thecervix, said second tubular member having a length at least that of thefenestrated portion of the first tubular member, and said first tubularmember having a hypodermic syringe attached to the proximal end thereof;

withdrawing the plunger of said hypodermic syringe causing a vacuum insaid first tubular member and sucking cell samples from the endometriumthrough said fenestrae,

withdrawing said first tubular member from the cer- VlX,

sliding said second tubular member over the fenestrae of the firsttubular member,

placing the fenestrated end of the first tubular member over amicroscope slide while the fenestrae are under the second tubularmember, and

pushing the plunger of said syringe to eject said cell samples onto saidmicroscope slide from said ejector port.

1. A method of preparing endometrial samples for microscopic examination comprising: inserting through the cervix one end of a first elongated flexible tubular member having an ejector port at said end and having fenestrae through the tubular wall adjacent said (end) ejector port and having a second tubular member having an internal diameter approximating the external diameter of said first tubular member and being slidably coaxially mounted on said first member at a position spaced from the cervix, said second tubular member having a length at least that of the fenestrated portion of the first tubular member, and said first tubular member having a hypodermic syringe attached to the proximal end thereof; withdrawing the plunger of said hypodermic syringe causing a vacuum in said first tubular member and sucking cell samples from the endometrium through said fenestrae, withdrawing said first tubular member from the cervix, sliding said second tubular member over the fenestrae of the first tubular member, placing the fenestrated end of the first tubular member over a microscope slide while the fenestrae are under the second tubular member, and pushing the plunger of said syringe to eject said cell samples onto said microscope slide from said ejector port. 